Indapamide-Teva, pills 2.5mg 30pcs

Composition

1 tablet contains:

Active ingredient:

indapamide hemihydrate 2.5 mg;

Auxiliary substances:

lactose monohydrate 63.5 mg,

corn starch 20.0 mg,

povidone 7.0 mg,

calcium phosphate dihydrate 3.0 mg,

magnesium stearate 1.5 mg,

talc 2.5 mg;

film coating:

Opadry ® OY-B-28920 2.5 mg (polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum).

Pharmacological action

Antihypertensive agent, a thiazide-like diuretic with moderate and long-lasting effects, a benzamide derivative. It has moderate saluretic and diuretic effects, which are associated with the blockade of reabsorption of sodium, chlorine, hydrogen and, to a lesser extent, potassium ions in the proximal tubules and cortical segment of the distal nephron tubule.

Vasodilating effects and a decrease in total peripheral vascular resistance are based on the following mechanisms: reduced reactivity of the vascular wall to norepinephrine and angiotensin II; increased synthesis of prostaglandins with vasodilating activity; inhibition of calcium flow into the smooth muscle walls of blood vessels.

Reduces the smooth muscle tone of the arteries, reduces the total peripheral vascular resistance. Helps to reduce hypertrophy of the left ventricle of the heart. In therapeutic doses, it does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).

The antihypertensive effect develops at the end of the first/beginning of the second week with constant use of the drug and persists for 24 hours against the background of a single dose.

Indications

Arterial hypertension.

Contraindications

Hypersensitivity to indapamide, other sulfonamide derivatives or other components of the drug, decompensation of renal function (anuria) and/or liver (including those with encephalopathy), hypokalemia, concomitant use of drugs that prolong the QT interval, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established).

Side effects

From the gastrointestinal tract:  nausea/anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation are possible.

Nervous system disorders:  asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely – increased fatigue, general weakness, malaise, muscle spasms, tension, irritability, anxiety.

From the side of the senses:  conjunctivitis, visual impairment.

Respiratory system disorders:  cough, pharyngitis, sinusitis, rarely-rhinitis.

From the cardiovascular system:  orthostatic hypotension, electrocardiogram changes (hypokalemia), arrhythmia, palpitations.

From the urinary system:  frequent infections, nocturia, polyuria.

Allergic reactions:  rash, urticaria, pruritus, hemorrhagic vasculitis.

Laboratory parameters:  hyperuricemia, hyperglycemia, hypokalemia, hypochloremia, hyponatremia, hypercalcemia, increased urea nitrogen in blood plasma, hypercreatininemia, glucosuria.

Other services:  flu-like syndrome, chest pain, back pain, infections, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, tingling of the extremities, pancreatitis, exacerbation of systemic lupus erythematosus.

Interaction

Saluretics, cardiac glycosides, gluco-and mineralocorticoids, tetracosactide, amphotericin B (iv), laxatives increase the risk of hypokalemia.

When taken concomitantly with cardiac glycosides, the likelihood of digitalis intoxication increases; with Ca 2+ drugs, hypercalcemia increases; with metformin, lactic acidosis may worsen. Increases the concentration of Li + ions in the blood plasma (reducing urinary excretion), lithium has a nephrotoxic effect.

Astemizole, intravenous erythromycin, pentamidine, sultoprid, terfenadine, vincamine, Class Ia antiarrhythmic drugs (quinidine, disopyramide) and Class III antiarrhythmics (amiodarone, bretilium, sotalol) can lead to the development of “torsades de pointes”arrhythmia. Nonsteroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen increases it.

Combination with potassium-sparing diuretics may be effective in some patients, however, the possibility of hypo – or hyperkalemia is not completely excluded, especially in patients with diabetes mellitus and renal insufficiency. Angiotensin-converting enzyme inhibitors increase the risk of hypotension and / or acute renal failure (especially with existing renal artery stenosis).

Increases the risk of developing impaired renal function when using high-dose iodine-containing contrast agents (dehydration of the body).

Before using iodine-containing contrast agents, patients need to restore fluid loss. Imipramine (tricyclic) antidepressants and antipsychotic drugs increase the hypotensive effect and increase the risk of orthostatic hypotension. Cyclosporine increases the risk of hypercreatininemia.

Reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of clotting factors as a result of a decrease in the volume of circulating blood and an increase in their production by the liver (dose adjustment may be required).

Increases the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.

How to take, course of use and dosage

Inside, preferably in the morning, regardless of food intake,2.5 mg (1 tablet) per day, washed down with a sufficient amount of liquid. The maximum daily dose is 1 tablet.

Overdose

Symptoms:  nausea, vomiting, weakness, impaired gastrointestinal function, water and electrolyte disorders, in some cases – excessive lowering of blood pressure, respiratory depression. Patients with cirrhosis of the liver may develop hepatic coma.

Treatment:  gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Special instructions

Regular monitoring of K + and creatinine levels is indicated in patients taking cardiac glycosides, laxatives, and hyperaldosteronism, as well as in the elderly.

While taking indapamide, the concentration of K+, Na+, and Md2+ ions in the blood plasma should be systematically monitored (electrolyte disturbances may develop), pH, glucose, uric acid, and residual nitrogen concentrations.

The most careful monitoring is indicated in patients with cirrhosis of the liver (especially with edema or ascites – the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, heart failure, as well as in the elderly.

The high-risk group also includes patients with an extended QT interval on an electrocardiogram (congenital or developed against the background of a pathological process).

The first measurement of the K + concentration in the blood should be carried out during the first week of treatment.

Hypercalcemia with indapamide may be a consequence of previously undiagnosed hyperparathyroidism. In patients with diabetes, it is extremely important to monitor blood glucose levels, especially in the presence of hypokalemia. Significant dehydration can lead to acute renal failure (decreased glomerular filtration rate) Patients should compensate for water loss and carefully monitor renal function at the beginning of treatment.

Indapamide can give a positive result during doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) should stop taking diuretics 3 days before the start of taking angiotensin-converting enzyme inhibitors (if necessary, diuretics can be resumed a little later), or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors. Sulfonamide derivatives can exacerbate the course of systemic lupus erythematosus (it is necessary to keep in mind when prescribing indapamide).

Application in pediatrics:  efficacy and safety in children have not been established.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf life

5 years

Active ingredient

Indapamide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets